Director, CMC Project Management
Location: Princeton, NJ (hybrid)
PMV Pharma is seeking an exceptional Director of CMC Project Management to oversee and manage Chemistry, Manufacturing, and Controls (CMC) activities for our drug development projects. The ideal candidate will have extensive experience in pharmaceutical R&D, a deep understanding of the small molecule drug development process, and a proven ability to deliver results in a fast-paced environment.
Key Responsibilities
- Work with CMC head to develop and manage detailed, integrated development plans for CMC projects, covering all phases of drug development.
- Lead the planning and execution of CMC projects, ensuring alignment with the overall development program strategy and timelines.
- Oversee the delivery of project objectives, focusing on meeting critical milestones and managing scope changes.
- Monitor project progress and performance, identifying areas for improvement and making necessary adjustments.
- Serve as the main point of contact for all CMC project-related communications, fostering strong relationships with internal teams and external partners.
- Facilitate effective collaboration across CMC functional teams (drug substance, drug supply, and analytical), ensuring alignment on project goals and priorities.
- Manage CMC related documents. Coordinate the preparation of high-quality regulatory submissions as needed.
- Assist the CMC technical leads with reviewing the reports and troubleshooting problems, as needed.
- Work with the clinical supply manager to ensure the adequate supply of clinical materials for patients
- Support the development and management of project budgets, forecasting, and reporting, focusing on cost control and resource optimization.
- Provide key updates on program progress, risks, and mitigation plans to management as needed.
- Stay abreast of industry trends, emerging technologies, and regulatory changes, applying this knowledge to enhance project outcomes.
Qualifications
Education/Experience and Skills Requirements:
- An advanced degree in science, preferably in organic chemistry.
- At least 10 years of pharmaceutical industry experience in small molecule drug development.
- At least 5 years of project management leadership experience, with a primary focus on CMC-related activities.
- Demonstrated understanding of the drug development process, including key disciplines involved in drug development (CMC, clinical, regulatory filing activities, etc.).
- Experience managing CDMO relationships and projects.
- Excellent attention to detail, communication, time management, and organizational skills, with a flexible attitude towards work assignments and new learning.
- Proven ability to interact effectively in a team environment.
- Strong cross-functional leadership in a matrix environment, with advanced skills in project management, organization, delegation, prioritization, and facilitation.
- Comfortable in a fast-paced, small company environment, with the ability to manage multiple projects simultaneously and handle rapidly changing information.
- Self-starter who functions well under minimal supervision.
- Expert MS Office skills, in addition to Adobe Acrobat and ChemDraw.
- Experience in solving technical problems to support CMC activities.
- Proven record of achievement and delivery of team goals.
- Proficiency in Mandarin is required.
Desired Attributes:
- Strong capability for logical, analytical, and strategic thinking
- Proven ability to develop and execute effective strategies
- Skillful and urgent issue resolution
- Strong leadership to support multi/complex projects in a small biotech environment
- Ability to interact, cooperate, and motivate across departments and functions
- Excellent leadership and communication skills
- Outstanding interpersonal skills
- Knowledge of project budgeting processes, including financial planning and expenditures
Travel Requirements: domestic and international, <10%
Benefits
- PMV provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, and stock options.
How to Apply
To apply, please submit your cover letter and resume to Recruiting@pmvpharma.com or apply through our Online Portal.
PLEASE, NO PHONE CALLS or AGENCIES
PMV Pharmaceuticals is an Equal Opportunity Employer and all applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
